As we have discussed in previous installments of “The Emergent Microbiome,” we have seen a distinct growth in the interest of the microbial communities found in our environment beyond the confines of the human body. Earlier articles in this series have focused on the microbiology of the built environment (See Part VII: The Microbiology of the Built Environment) and the microbial communities of plants that have been characterized and manipulated to maximize their growth and crop yield (See Part XI: Agriculture and the Microbiome). In both circumstances, we noted robust intellectual property activity. Likewise, we have also observed an increased interest in the microbial communities found in livestock animals, and how manipulations of these communities could result in more effective, productive, and sustainable means of food production. Although this area is less well developed than other areas of microbiome research, including that of plant agriculture, we see it as a promising area of development in terms of both the science and the innovation that will inevitably flow from it.

Knowledge of, and interest in, the human microbiome has rapidly expanded in recent years: each week, there seems to be additional advancements in our understanding of the microbial communities that call our bodies home. As investigations into these microbial communities and their impact on our health continue to develop, many researchers have rightfully begun to untangle the web of microbial communities external to us (See Part VII, The Microbiology of the Built Environment). In particular, we have observed an increased interest in the microbial communities associated with agriculture and crops. Having a clearer understanding of agriculture-associated microbial communities, and how they can be manipulated and modulated, will play an increasingly important role in the safety and security of our food supply. In fact, we have seen several encouraging efforts devoted to the advancement of microbiome research in agriculture, and we expect to see a subsequent increase in the need for intellectual property protection in this space. Importantly, we also see a clear path forward for patent-eligible inventions in this historically challenging area. While this article will focus on agriculture and the microbiome, we have also observed an increase in the attention being given to livestock production and the microbiome. In an upcoming installment of The Emergent Microbiome, we will address the history, importance, and advancements with respect to this field of research and related intellectual property issues and challenges.

Recent decisions from the United States Court of Appeals for the Federal Circuit from 2016 and 2017 suggest a loosening grip and increasing flexibility of the two-part Mayo/Alice framework that has dominated the question of patent subject matter eligibility under 35 U.S.C. § 101. In fact, in 2014 after the Alice decision, just one Federal Circuit case addressing 101 challenges was ruled to have eligible claims. Although there were no 101 eligibility affirmations in 2015, there were five such cases in 2016 alone. Fewer than five months into 2017, there have now already been two 101 decisions from the Federal Circuit finding patent eligible claims (see Figure 1 and Table 1).

On Monday May 22, the Supreme Court ruled on the much-anticipated decision in TC Heartland v. Kraft Foods, a case that many viewed as having the potential to upend the question of patent venue in patent litigation. In a unanimous decision (8-0, Justice Gorsuch took no part in this case), the Court ruled in favor of TC Heartland, stating that, “a domestic corporation “resides” only in its State of incorporation for purposes of the patent venue statute.”

On Monday March 27, the Supreme Court heard oral arguments in the case of TC Heartland v. Kraft Foods, a case that has potentially vast implications on patent venue, a fundamental issue in the area of patent litigation. Currently, patentees can bring suit in any district court, even if they do not have a business presence in that district. Whether this practice should continue or be overturned is the crux of the issue heard at the Supreme Court.

In January, the United States Food and Drug Administration (FDA) released a draft guidance entitled, “Considerations in Demonstrating Interchangeability” aimed at helping to implement the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This guidance serves to directly address the issue of demonstrating interchangeability of biological products and the standards required to do so. Interestingly, no product has yet been shown to be interchangeable, including the four biosimiliars that have already been approved by the FDA.

Last week, the United States Patent and Trademark Office’s (USPTO) Patent and Trademark Appeal Board (PTAB) handed down its decision in the contentious CRISPR patent battle between UC Berkeley and the Broad Institute. Somewhat unsurprisingly, the PTAB ruled that there existed no interference-in-fact between the patents and patent applications held by the Broad Institute and those held by UC Berkeley. In short, the PTAB was looking to whether the Broad Institute claims and the UC Berkeley claims were overlapping and if so, would have determined which party had first made the invention. The PTAB clearly stated there exists no overlap, or interference-in-fact, meaning that each institution will be allowed to license and assert its patents as it wishes, granting a victory to the Broad Institute in what has evolved into an extended, and at times, a bitter CRISPR patent battle.

Research into the human microbiome has resulted in such unprecedented amounts of data that challenges related to both interpretation and management have emerged. Somewhat paradoxically, current statistical methods have made it such that it is more difficult and less likely to identify statistically significant results from large data sets. We see much potential for the expansion of intellectual property protection in the area of big data related to the microbiome, not only as a result of recent research advances and the desire to better and more efficiently handle big data, but also because of several recent Federal Circuit decisions in intellectual property law that provide some promising guidance for protecting software and computing information that may be required for managing and interpreting microbiome-related data. Moreover, the United States Patent and Trademark Office (USPTO) has provided examples for crafting potentially patent eligible claims in this space, a promising step forward in what has become a difficult area for IP protection.

In late December, the United States Patent and Trademark Office (USPTO) released a series of subject matter eligibility examples meant to provide guidance for drafting claims pertaining to business methods. This is the first time that the USPTO has issued guidance on such matters. The examples, labeled 34, 35, and 36, serve to clarify the validity of claims pertaining to abstract matters under 35 U.S.C. § 101 and focus on a system for filtering internet content, verifying a bank customer’s identity to permit an ATM transaction, and tracking inventory, respectively. Interestingly, while the fact patterns and claims of 35 and 36 are hypothetical, example 34 is taken directly from BASCOM Global Internet v. AT&T Mobility LLC where the claims were ruled eligible by the Federal Circuit in 2016. BASCOM has played an important role in the changing landscape of software-related patents.

Back in December, the Supreme Court accepted a petition in the case of TC Heartland v. Kraft Foods, one of the few patent-centric cases recently taken up by the Court. Interestingly, for this review, the case does not focus on the claims or scope of a particular patent, but instead on a fundamental question in patent litigation: that of venue. The implications for this case are vast. Currently, the Eastern District of Texas is a desired district for litigating patent cases. Should the Supreme Court overturn the Federal Circuit’s ruling on patent venues, which states that patentees can bring suit in a district even if they do not have a business presence in that district, the redistribution of patent litigation could be both swift and unpredictable.